Efficacy of pimecrolimus in normalizing clinical symptoms, explorative study of barrier function, hydration, lipid content and differentiation in seborrheic dermatitis
Conditions
Interventions
Trade Name: elidel 1% cream
Pharmaceutical Form: Cream
INN or Proposed INN: PIMECROLIMUS
CAS Number: CASM981A2206
Other descriptive name: Elidel
Concentration unit: % percent
Concentration type: equal
Sponsors
Department of Dermatology, University of Kiel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Males and females of any race. · >= 18 years old. · Have mild to severe seborrheic dermatitis as defined by clinical criteria. At least 50 % of the subjects must meet the criteria for moderate or severe seborrheic dermatitis (F-IGA 2 and 3) and at least 5 subjects of each group must show lesions on the trunk. · At least 10 % of the face must be affected by seborrheic dermatitis, excluding the surface area of the scalp, as this area is inappropriate for treatment with cream preparations. · One specific, representative area of the disease on the face will serve as area for F-IGA scoring. This will be considered the target lesion. · To be able to suspend treatment of seborrheic dermatitis with other therapies for the duration of the study (4-6 weeks). · Must be informed of study procedures and have signed the informed consent form approved for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Females: · Who are pregnant or breastfeeding. · Who are menstruating, capable of becoming pregnant and not practicing a medically approved method of contraception. “Medically approved” contraceptive may, at the discretion of the investigator, include abstinence. (If patients are on oral contraceptives, they must have begun treatment at least one month prior to baseline and continue at least four weeks after the last treatment). Other therapies/medications: · Prior phototherapy or systemic therapy known to or suspected to have an effect on seborrheic eczema within 14 days prior to first application of study medication. Patients on a low stable dose of inhaled steroids (dose known to have negligible systemic absorption) and systemic antihistamines may participate. · Topical therapy known to or suspected to have an effect on seborrheic dermatitis (including topical steroids, topical tacrolimus ointment or topical pimecrolimus cream) on the face or trunk lesions within 7 days prior to first application of study medication. Concurrent diseases / conditions and history of their diseases / conditions: · Patients who have signs of skin atrophy and corticoid damage on the target areas. · Patients who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich Syndrome) · Patients who have concurrent skin disease (e.g. impetigo, atopic dermatitis, ) on or near the study area which could interfere with study evaluations · Patients who have acute viral skin infections (e.g. herpes simplex, varicella zoster) Investigational drug / therapy use. · Patients who have used investigational drugs within 8 weeks prior to first application of study medication or intend to use other investigational drugs during the course of the study Ingredient hypersensitivity · Patients with known hypersensitivity to any ingredient of the study medication (see technical information sheet) Compliance / reliability / investigator judgment · Patients who are, in the opinion of the investigator, known to be unreliable or non-compliant with medical treatment, or are known to miss appointments (according to patient records) · Patients who drug abuse problems, mental dysfunction or other factors limiting their ability to cooperate fully · Patients who any other condition or prior/present treatment which, in the opinion of the investigator, will render the patient ineligible for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1 % pimecrolimus cream is the superior treatment method for normalizing clinical condition of seborrheic dermatitis of the face (and trunk if affected) after one week of treatment compared to standard 2 % ketoconazole cream therapy using F-IGA scoring. ;Secondary Objective: 1)1 % pimecrolimus cream is the superior treatment method for normalizing clinical condition of seborrheic dermatitis of the face (and trunk if affected) after four weeks of treatment compared to standard 2 % ketoconazole cream therapy using F-IGA scoring, pruritus scoring, and using scoring of erythema and scaling, cosmetic acceptability assessment as additional parameters. 2)1 % pimecrolimus cream normalizes the biophysical parameters of seborrheic dermatitis representing the permeability barrier of the skin (transepidermal water loss) and stratum corneum hydration (corneometry) after four weeks of treatment. 3)To explore the epidermal effects of 1 % pimecrolimus cream compared to standard 2 % ketoconazole cream in lesions on the trunk on epidermal proliferation, differentiation and stratum corneum lipid content. 4)To explore the effect of 1 % pimecrolimus cream induced changes in Malassezia counting. ;Primary end point(s): To explore the effect of 1 % pimecrolimus cream in adults with seborrheic dermatitis versus 2 % ketoconazole cream by testing the hypothesis that: 1 % pimecrolimus cream is the superior treatment method for normalizing clinical condition of seborrheic dermatitis of the face (and trunk if affected) after one week of treatment compared to standard 2 % ketoconazole cream therapy using F-IGA scoring. | — |
Countries
Germany
Outcome results
None listed